U.S. patent number 9,554,886 [Application Number 13/866,681] was granted by the patent office on 2017-01-31 for medical assembly with tactile feedback.
This patent grant is currently assigned to Boston Scientific Scimed, Inc.. The grantee listed for this patent is Boston Scientific Scimed, Inc.. Invention is credited to Michael S. H. Chu, Kenneth M. Flynn, James M. Goddard, Sharmad S. Joshi.
United States Patent |
9,554,886 |
Chu , et al. |
January 31, 2017 |
Medical assembly with tactile feedback
Abstract
The present invention discloses a medical assembly including an
implant, a first sleeve, a second sleeve and an elongate member.
The implant has a first portion, a second portion and a mid
portion. The first portion of the implant is configured to be
enclosed by the first sleeve and the second portion of the implant
is configured to be enclosed by the second sleeve. The elongate
member is configured to couple the implant with the first sleeve
and the second sleeve and is configured to respectively extend from
the first portion to the mid portion of the implant and past the
mid portion such that the elongate member exits the implant through
the mid portion and forms a loop near the mid portion.
Inventors: |
Chu; Michael S. H. (Brookline,
MA), Flynn; Kenneth M. (Woburn, MA), Joshi; Sharmad
S. (Natick, MA), Goddard; James M. (Pepperell, MA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Boston Scientific Scimed, Inc. |
Maple Grove |
MN |
US |
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Assignee: |
Boston Scientific Scimed, Inc.
(Maple Grove, MN)
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Family
ID: |
49380824 |
Appl.
No.: |
13/866,681 |
Filed: |
April 19, 2013 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20130282034 A1 |
Oct 24, 2013 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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61636902 |
Apr 23, 2012 |
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61745101 |
Dec 21, 2012 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/0063 (20130101); A61F 2/0045 (20130101); A61B
2017/0608 (20130101); A61F 2250/0007 (20130101); A61B
2017/00805 (20130101); A61B 17/06109 (20130101); A61F
2250/0091 (20130101); A61F 2250/0097 (20130101); A61B
90/90 (20160201) |
Current International
Class: |
A61F
2/02 (20060101); A61F 2/00 (20060101); A61B
17/06 (20060101); A61B 17/00 (20060101) |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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CN |
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101128163 |
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Feb 2008 |
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CN |
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101686855 |
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Mar 2010 |
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CN |
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101795640 |
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Aug 2010 |
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CN |
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101801281 |
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Aug 2010 |
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CN |
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102083389 |
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Jun 2011 |
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CN |
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2006517115 |
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Jul 2006 |
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JP |
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2004/016180 |
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Feb 2004 |
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WO |
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2008/042433 |
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Apr 2008 |
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WO |
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2010/121053 |
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Oct 2010 |
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WO |
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2011/026494 |
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Apr 2011 |
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WO |
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Other References
International Search Report and Written Opinion for PCT Patent
Application No. PCT/US2013/037551, mailed Jul. 2, 2013, 10 pages.
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International Preliminary Report on Patentability for PCT Patent
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cited by applicant .
First Examiner Report for Australian Patent Application No.
2013252558, mailed on Nov. 18, 2014, 3 pages. cited by applicant
.
Office Action for Chinese Patent Application No. 201380021319.6,
mailed on Jul. 22, 2015, 8 pages. cited by applicant .
Office Action for Canadian Patent Application No. 2,865,196, mailed
on Aug. 20, 2015, 4 pages. cited by applicant .
Notice of Acceptance for AU Application No. 2013252558, mailed Sep.
18, 2015, 57 pages. cited by applicant .
Response to Notice of Acceptance for AU Application No. 2013252558,
filed Sep. 16, 2015, 10 pages. cited by applicant .
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2,865,196, filed on Feb. 19, 2016, 6 pages. cited by applicant
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Office Action for Chinese Patent Application No. 201380021319.6,
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Primary Examiner: Rodjom; Katherine
Attorney, Agent or Firm: Brake Hughes Bellermann LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a nonprovisional of, and claims priority to,
U.S. Patent Application No. 61/745,101, filed on Dec. 21, 2012,
entitled "MEDICAL ASSEMBLY WITH TACTILE FEEDBACK", and also claims
priority to U.S. Patent Application No. 61/636,902, filed on Apr.
23, 2012, entitled "MEDICAL ASSEMBLY WITH TACTILE FEEDBACK", both
of which are incorporated by reference herein in their entirety.
Claims
What is claimed is:
1. A medical assembly comprising: an implant having a first
portion, a second portion and a mid portion between the first
portion and the second portion; a first sleeve configured to
enclose the first portion of the implant and a second sleeve
configured to enclose the second portion of the implant; a tab
coupled to the implant; a first elongate member configured to
removably couple the implant with the first sleeve, wherein the
first elongate member extends from the first portion to the mid
portion of the implant and past the mid portion and exits the
implant through the mid portion; a second elongate member
configured to removably couple the implant with the second sleeve,
wherein the second elongate member extends from the second portion
to the mid portion of the implant and past the mid portion and
exits the implant through the mid portion; wherein the first
elongate member and the second elongate member are coupled to the
tab and to each other at the tab; and a third elongate member
configured to pass through the mid portion of the implant and form
a loop configured to couple the mid portion of the implant with the
tab.
2. The medical assembly of claim 1, wherein the first sleeve and
the second sleeve together encloses a maximum of half of a total
length of the implant.
3. The medical assembly of claim 1, wherein the first sleeve and
the second sleeve are thin walled flat tubes configured to enclose
at least some portion of the implant at ends.
4. The medical assembly of claim 1 further comprising a first
dilator configured to be coupled to the first sleeve, and a second
dilator configured to be coupled to the second sleeve.
5. The medical assembly of claim 1, wherein the first elongate
member, the second elongate member and the third elongate member
include one of a thread, and a medical suture.
6. The medical assembly of claim 1, wherein each of the first
elongate member and the second elongate member has a single suture
running along a portion of length of the implant.
7. The medical assembly of claim 1, wherein each of the first
elongate member and the second elongate member has multiple sutures
running along a portion of length of the implant adjacent one
another.
8. A medical assembly comprising: an implant having a first
portion, a second portion and a mid portion between the first
portion and the second portion; a first sleeve configured to
enclose the first portion of the implant and a second sleeve
configured to enclose the second portion of the implant; and an
elongate member configured to removably couple the implant with the
first sleeve and the second sleeve, wherein the elongate member is
configured to extend from the first portion to the mid portion of
the implant and past the mid portion such that the elongate member
exits the implant through the mid portion and forms a loop near the
mid portion, the elongate member further configured to enter the
implant through the mid portion and extend from the mid portion to
the second portion of the implant, the elongate member including a
first free end and a second free end such that pulling on either
the first free end or the second free end decouples the first
sleeve and the second sleeve from the implant.
9. The medical assembly of claim 8, wherein the implant is coupled
to both the first sleeve and the second sleeve via the elongate
member which is a single elongate member.
10. The medical assembly of claim 8, wherein the first sleeve and
the second sleeve together encloses a maximum of half of a total
length of the implant.
11. The medical assembly of claim 8, further comprising a first
dilator configured to be coupled to the first sleeve, and a second
dilator configured to be coupled to the second sleeve.
12. The medical assembly of claim 8, wherein the first sleeve and
the second sleeve are thin walled flat tubes configured to enclose
at least a portion of the implant.
13. A medical assembly comprising: an implant having a first
portion, a second portion and a mid portion between the first
portion and the second portion; a sleeve with a top layer, a bottom
layer, and a lumen defined between the top layer and the bottom
layer, a first hole provided on the top layer, a second hole
provided on the bottom layer, wherein the first hole and the second
hole are respectively defined along a thickness of the top layer
and the bottom layer; an elongate member configured to pass through
the first hole, along the lumen and the second hole and couple the
implant with the sleeve; and a tab configured to be coupled to the
implant, the tab including a first end portion, a mid portion, and
a second end portion, the mid portion having a width smaller than a
width of the first end portion, the width of the mid portion being
smaller than a width of the second end portion.
14. The medical assembly of claim 13, wherein the sleeve is a first
sleeve, the medical assembly further including a second sleeve with
a top layer, a bottom layer, and a lumen defined between the top
layer and the bottom layer, a first hole provided on the top layer,
a second hole provided on the bottom layer, wherein the first hole
and the second hole are respectively defined along a thickness of
the top layer and the bottom layer of the second sleeve.
15. The medical assembly of claim 14, wherein the elongate member
is a first elongate member, the medical assembly further including
a second elongate member configured to pass through the first hole,
along the lumen and the second hole and couple the implant with the
second sleeve.
16. The medical assembly of claim 14, wherein the tab is configured
to be coupled with the implant through a third elongate member.
17. The medical assembly of claim 13, wherein the implant is a mesh
based device, the elongate member configured to pass through a mesh
cell of the implant.
18. The medical assembly of claim 13, wherein the implant is a
non-mesh based device, the non-mesh based device further including
a hole configured to facilitate passing of the elongate member
along the implant through the hole.
19. The medical assembly of claim 13, wherein the elongate member
includes a portion laid at a surface external to the top layer or
the bottom layer that is configured to provide a slack in the
elongate member and configured to facilitate decoupling of the
sleeve from the implant.
Description
BACKGROUND
Field
The present invention generally relates to surgical devices and
procedures, particularly devices and methods for the delivery of
implants within a patient's body.
Description of the Related Art
Pelvic health for men and women is a medical area of high
importance. Examples of common pelvic ailments include incontinence
(e.g. fecal and urinary), pelvic tissue prolapse (e.g. female
vaginal prolapse), and other conditions of the pelvic floor.
Many surgical options have been developed for the correction of
Urinary Incontinence due to hypermobility and/or Intrinsic
Sphincteric Deficiency. One type of surgical procedure found to be
a successful treatment option is an implant-based procedure. It
involves placement of bodily implants under a bladder neck or a
mid-urethra or any other location to provide a support
platform.
Some slings or implants for incontinence repair are delivered with
long sleeves that cover or enclose the implant and protect bodily
tissues. A sleeve can be a single piece sleeve or a two piece
sleeve that are attached on contra lateral sides and joined near
the midpoint. The tension of the sling is then adjusted based on
patient requirements after delivery within the body. In some cases,
an additional tension may be inadvertently induced while removal of
the sleeves. Since the sling is almost completely enclosed or
confined within the single piece or connected sleeve, the sleeve
may not allow the sling to stretch properly during adjustment or
positioning. This may also not allow the sling to conform to the
contour of dissected anatomy to allow the physician to feel or
gauge correct positioning or tension of the sling.
Further, some existing sleeves contact the sling over a large
surface area. This may result in an increased frictional resistance
between the sling material and the sleeve material that opposes
pulling of sleeve from the sling during removal. As a result, the
frictional resistance may reposition the sling or disturb the sling
location or tension. For example, in some cases, the sling may get
stretched more than required while in other cases, it may be
loosened. And, both the situations may yield in an inappropriate
sling placement; and hence, an ineffective or wrong or incorrect
treatment.
In view of the above, there is a need of a method and a device that
allows removal of the sleeves from the implant without altering the
sling tension or location and also provides an operator with an
improved visual and tactile feedback to adjust or readjust the
implant.
SUMMARY
In an embodiment, the present invention discloses a medical
assembly including an implant, a first sleeve, a second sleeve, and
a tab. The implant has a first portion, a second portion, and a mid
portion between the first portion and the second portion. The first
portion of the implant is configured to be enclosed by the first
sleeve and the second portion of the implant is configured to be
enclosed by the second sleeve. The implant is further coupled to
the tab. The medical assembly further includes a first elongate
member, a second elongate member, and a third elongate member. The
first elongate member is configured to removably couple the implant
with the first sleeve such that the first elongate member extends
from the first portion to the mid portion of the implant and past
the mid portion and exits the implant through the mid portion. The
second elongate member is configured to removably couple the
implant with the second sleeve such that the second elongate member
extends from the second portion to the mid portion of the implant
and past the mid portion and exits the implant through the mid
portion. The first elongate member and the second elongate member
further are coupled to the tab and to each other at the tab. The
medical assembly further includes the third elongate member such
that the third elongate member is configured to pass through the
mid portion of the implant and form a loop configured to couple the
mid portion of the implant with the tab.
In another embodiment, the present invention discloses a medical
assembly including an implant and a first sleeve and a second
sleeve. The implant has a first portion, a second portion and a mid
portion between the first portion and the second portion. The first
portion of the implant is configured to be enclosed by the first
sleeve and the second portion of the implant is configured to be
enclosed by the second sleeve. The medical assembly further
includes an elongate member configured to removably couple the
implant with the first sleeve and the second sleeve. The elongate
member extends from the first portion to the mid portion of the
implant and past the mid portion such that the elongate member
exits the implant through the mid portion and forms a loop near the
mid portion. The elongate member is further configured to enter the
implant through the mid portion and extend from the mid portion to
the second portion of the implant.
In yet another embodiment, the present invention discloses a
medical assembly including an implant, a sleeve and an elongate
member. The implant has a first portion, a second portion and a mid
portion between the first portion and the second portion. The
sleeve includes a top layer, a bottom layer, and a lumen defined
between the upper layer and the bottom layer, a first hole provided
on the top layer and a second hole provided on the bottom layer.
The first hole and the second hole are respectively defined along a
thickness of the top layer and the bottom layer. The medical
assembly further includes the elongate member that is configured to
pass through the first hole, along the lumen and the second hole
and couple the implant with the sleeve.
In yet some other embodiment, the present invention discloses a
method for placing an implant for the treatment of urinary
incontinence in a patient's body. The method includes inserting a
medical assembly having a bodily implant into a patient's body such
that a first end portion and a second end portion of the bodily
implant are enclosed in a first sleeve and a second sleeve
respectively. The first sleeve is coupled to the implant by an
elongate member through frictional resistance. The method further
includes placing the implant underneath a urethra of a patient such
that a mid portion of the implant is exposed to a bodily tissue.
Upon positioning of the implant, the elongate member is pulled
outside the patient's body such that a pulling of the elongate
member releases the first sleeve from the bodily implant. In some
embodiments, the first sleeve is pulled out in a direction
substantially different to a direction of pulling the elongate
member.
BRIEF DESCRIPTION OF THE FIGURES
The invention and the following detailed description of certain
embodiments thereof may be understood with reference to the
following figures:
FIG. 1 is a schematic diagram of a medical assembly, in accordance
with some embodiments of the present invention.
FIGS. 2A-2G are different views of a medical assembly, in
accordance with various embodiment of the present invention.
FIG. 2H illustrates an enlarged view of a portion of a medical
assembly, in accordance with an embodiment of the present
invention.
FIG. 2I is a cross-sectional side view of a portion of a medical
assembly, in accordance with an embodiment of the present
invention
FIG. 2J is a perspective view of a medical assembly, in accordance
with an embodiment of the present invention.
FIG. 3A is a perspective view of a medical assembly, in accordance
with an embodiment of the present invention.
FIGS. 3B, 3C, and 3D illustrate front views of a portion of a
medical assembly, in accordance with some embodiments of the
present invention.
FIGS. 3E and 3F are perspective views of a medical assembly in
accordance with some embodiments of the present invention.
FIG. 3G is a top view of a medical assembly in accordance with an
embodiment of the invention.
FIG. 3H is a bottom view of the medical assembly of FIG. 3G.
FIGS. 3I, 3J, and 3K are perspective views of portions of the
medical assembly of FIG. 3G.
FIG. 3L is a schematic view of an implant of the medical assembly
of FIG. 3G disposed within a body of a patient
FIGS. 4A and 4B illustrate perspective and cross-sectional views
respectively of a sleeve with C configuration coupled to an
implant, in accordance with an embodiment of the present
invention.
FIGS. 4C and 4D illustrate perspective and cross-sectional views
respectively of a sleeve with U configuration coupled to an
implant, in accordance with an embodiment of the present
invention.
FIG. 5 is perspective view of an association skive, in accordance
with an embodiment of the present invention.
FIG. 6 is perspective view of a sleeve, in accordance with an
embodiment of the present invention.
FIG. 7 illustrates delivery of a medical assembly for placement of
an implant in a patient's body, in accordance with an embodiment of
the present invention.
FIG. 8 illustrates a flow chart depicting the method of delivery of
a medical assembly, in accordance with various embodiments of the
present invention.
DETAILED DESCRIPTION
Detailed embodiments of the present invention are disclosed herein;
however, it is to be understood that the disclosed embodiments are
merely exemplary of the invention, which may be embodied in various
forms. Therefore, specific structural and functional details
disclosed herein are not to be interpreted as limiting, but merely
as a basis for the claims and as a representative basis for
teaching one skilled in the art to variously employ the present
invention in virtually any appropriately detailed structure.
The terms "a" or "an," as used herein, are defined as one or more
than one. The term "another," as used herein, is defined as at
least a second or more. The terms "including" and/or "having", as
used herein, are defined as comprising (i.e., open transition).
The terms proximal and distal described in relation to various
medical devices, apparatuses, and components, as discussed in the
subsequent text of the present invention, are referred with a point
of reference. The point of reference, as used in this description,
is a perspective of an operator. The operator may be a surgeon, a
physician, a nurse, a doctor, a technician, and the like, who may
perform the procedure of surgery through the patient's body orifice
or incision as described in the present invention. The term
proximal refers to an area that is closest to the operator. The
term distal refers to an area that is farthest from the operator.
The patient can be a male, a female or any other mammal.
FIG. 1 is a schematic diagram of a medical assembly 100, in
accordance with some embodiments of the present invention. The
medical assembly 100 includes an implant 102, a first sleeve 104, a
second sleeve 106, a tab 108, a first elongate member 110, a second
elongate member 112, and a third elongate member 114.
The implant 102 has a first portion 116, a second portion 118, and
a mid portion 120 between the first portion 116 and the second
portion 118 with a length 122 of the implant 102, extending between
the first portion 116 and the second portion 118 longitudinally. In
accordance with various embodiments, the implant 102 can have a
variety of shapes such as rectangular, square, trapezoidal, and the
like.
In some embodiments, the mid portion of the implant 102 is
de-tanged (without tangs). The length of the de-tanged section can
vary based on surgical requirements or location of placement inside
the patient's body. In some embodiments, the first portion 116 and
the second portion 118 may include tangs such that upon placement
of the implant 102, the first portion 116 and the second portion
118 of the implant 102 can interact with bodily tissues to help
anchor or retain the implant in position within the body of the
patient. In some embodiments, the de-tanged section can be made by
fusing threads or strands of a mesh edge together by heat. The
de-tanged section may, in some embodiments, prevent unraveling of
the implant 102 when in tension and thus limits its stretch.
In some embodiments, the implant 102 is made of a synthetic
material such as a polymeric material and the like. In some
embodiments, the implant 102 includes a polymeric mesh body. The
mesh body may comprise a crisscrossed or chain link fence-like
design. In such designs, the fibers or strands of the mesh may be
woven, linked, or otherwise connected, and may share the stress of
a supported load. In other embodiments, the implant 102 includes a
polymeric planar body without mesh cells and structures. Exemplary
polymeric materials are polypropylene, polyester, polyethylene,
nylon, PVC, polystyrene, and the like. In some embodiments, the
implant is made of a non-woven polymeric material. In some other
embodiments, the implant 102 can be made of natural materials such
as biologic material or a cadaveric tissue and the like.
Additionally, in some embodiments, the implant 102 is stretchable
and flexible to adapt movements along the anatomy of the human
body. In some embodiments, the attributes such as softness,
lightness, conformity and strength are required in the implant 102
for efficient tissue repair and implantation. In some embodiments,
the implant 102 can be blue in color or any other color that
facilitates distinguishing the implant 102 from the sleeves 104 and
106.
As mentioned above, the medical assembly 100 includes the first
sleeve 104 configured to enclose the first portion 116 of the
implant 102 and the second sleeve 106 configured to enclose the
second portion 118 of the implant 102. Each of the first sleeve 104
and the second sleeve 106 includes a proximal end portion 124 and
126 and a distal end portion 128 and 130 with a length 132 and 134
extending between the proximal end portion 124 and 126 and the
distal end portion 128 and 130 such that the length 132 of the
first sleeve 104 is sufficient to envelop or shield the first
portion 116 of the implant and length 134 of the second sleeve 106
is sufficient to shield the second portion 118 of the implant 102.
In various embodiments, the first portion 116 is a first end
portion of the implant 102 and the second portion 118 is the second
end portion of the implant 102 such that the first sleeve 104 and
the second sleeve 106 are configured to enclose the first end
portion and the second end portion, respectively, of the implant
102. The first sleeve 104 and the second sleeve 106 are together
hereafter referred to as sleeves 104 and 106 for simplicity of the
description.
In some embodiments, the sleeves 104 and 106 are shaped in the form
of hollow tubes or envelopes such that a hollow space within the
sleeves 104 and 106 define lumen 136 and 138 therein. The lumen 136
and 138 of the sleeves 104 and 106 are configured to receive the
first portion 116 and the second portion 118 that are the first end
portion and the second end portion of the implant 102. The first
end portion and the second end portion may be respectively disposed
within the lumen 136 and 138 of the first sleeve 104 and the second
sleeve 106. In some embodiments, the implant 102 may be
free-floating within the first sleeve 104 and the second sleeve
106. Alternatively, the implant 102 may be fixed to the sleeves 104
and 106.
The lumen 136 and 138 of the sleeves 104 and 106 have a width 140
and 142 that is larger than the width of the implant 102 at the
first and the second end portion 116 and 118 that are configured to
be covered by the sleeves 104 and 106. This allows housing of the
end portions 116 and 118 of the implant 102 within the lumen 136
and 138 of the sleeves 104 and 106. In some other embodiments, the
proximal end portions 124 and 126 of the sleeves 104 and 106 are
slightly tapered to facilitate the withdrawal without disrupting
the tissues. In some embodiments, the sleeves 104 and 106 can be
made of resilient or flexible material such that the width of the
lumen 136 and 138 is smaller than the width of the implant 102 in a
normal condition. However, in some embodiments, the sleeves 104 and
106 are configured to be stretched due to its flexible material;
the width of the lumen 136 and 138 can be increased to an extent
that makes the receipt of the implant 102 possible within the lumen
136 and 138.
In some embodiments, the sleeves 104 and 106 are made of polymer
and may be colored blue. In other embodiments, the sleeves 104 and
106 can be manufactured from an opaque or a transparent plastic
film. The transparent plastic film enables visual examination of
the implant 102. The sleeves 104 and 106 can be single or multiple
ply. The sleeves 104 and 106 can be made by extruding or
sandwiching two sheets of polymer together. In general, the sleeves
104 and 106 may be composed of any biocompatible material known in
the art. Such materials may include, for example, polyethylene,
PTFE, and EPTFE. The sleeves 104 and 106 may be composed of one
material or, in some embodiments, the sleeves 104 and 106 may be
made of a multilayered structure composed of one or more materials
already mentioned. The sleeves 104 and 106 may be any length or
width useful for implanting and positioning the implant 102 within
the body of the patient, and may be flexible and easily manipulable
when the implant 102 is disposed therein. In various embodiments
described herein, the sleeves 104 and 106 may be long enough and
wide enough to define the lumen 136 and 138 that is appropriately
sized for accepting the first end portion and the second end
portion.
As per the various embodiments of the present invention described
above, the first portion 116 of the implant 102 enclosed by the
first sleeve 104 and the second portion 118 of the implant 102
enclosed by the second sleeve 106 facilitate in a non-binding
release or withdrawal of the first sleeve 104 and the second sleeve
106 from the implant 102. The non-binding removal of the sleeves
104 and 106 implies that the sleeves 104 and 106 are held with the
implant 102 only through a frictional resistance that is capable to
hold them but not large enough to cause any damage to the implant
102 during pulling or removal. This may reduce additional tension
that can be induced to the implant 102 as the sleeves 104 and 106
are pulled or released off the implant 102.
In accordance with some embodiments, the sleeves 104 and 106 are
configured to enclose the end portions 116 and 118 of the implant
102 such that only a small surface area of the implant 102 comes in
contact with the sleeves 104 and 106. In an embodiment of the
present invention, the first sleeve 104 and the second sleeve 106
together encloses a maximum of half of a total length 122 of the
implant 102. In some embodiments, the first sleeve 104 and the
second sleeve 106 together encloses less than half of the total
length 122 of the implant 102. In some other embodiments, the first
sleeve 104 and the second sleeve 106 together encloses half of the
total length 122 of the implant 102. In some other embodiments, the
first sleeve 104 and the second sleeve 106 together encloses about
half of the total length 122 of the implant 102. In some other
embodiments, the first sleeve 104 and the second sleeve 106 may
together enclose slightly or substantially more than half of the
total length 122 of the implant 102. With a small surface area
contact between the implant 102 and the sleeves 104 and 106, the
friction between the implant 102 and the sleeves 104 and 106 is
less to disrupt the implant tension, leading to a more precise
implant placement.
In some embodiments, the sleeves 104 and 106 can have a C
configuration, as shown in FIGS. 4A and 4B later. In the C
configuration, the sleeves 104 and 106 encloses the implant 102 in
a manner that a first side (right side), a second side (left side),
some portion of a first surface (top surface), and a second surface
(bottom surface) of the implant 102 are enclosed, whereas some
portion of the first surface (top surface) is exposed to bodily
tissues is are not shielded within the sleeves 104 and 106. The
"some portion" can be along half of the width of the sleeves 104
and 106, or about half of the width or lesser than half of the
width or slightly more than half of the width, and the like as per
the requirements. In some other embodiments, the sleeves 104 and
106 can have a U configuration. The U configuration encloses the
first side, the second side and the second surface (bottom surface)
while the first surface (top surface) of the implant 102 is
completely exposed to the bodily tissues and not shielded within
the sleeves 104 and 106. The U configuration of the sleeves 104 and
106 is illustrated and described in conjunction with FIGS. 4C and
4D later. The sleeves 104 and 106 may have a slit along its length
132 and 134 in which the implant 102 can be held.
In some embodiments, a distal portion of the sleeves 104 and 106 is
configured with a taper and a loop or a hole, dilator, tube,
connector or the like to be used to associated to a delivery
device. The delivery device is further described later.
In certain embodiments of the present invention, the medical
assembly 100 may also include a first dilator configured to be
coupled to the first sleeve 104, and a second dilator configured to
be coupled to the second sleeve 106. The first dilator and the
second dilator are configured to be coupled respectively to the
distal ends 128, and 130 of the first sleeve 104 and the second
sleeve 106. In some embodiments, the first and the second dilator
are further configured to be coupled to a delivery device. The
delivery device is a medical instrument that can be used to
facilitate delivery of the medical assembly 100 including the
implant 102 within the patient's body. A few examples of delivery
devices may include the Boston Scientific Corporation Obtryx.TM.,
Lynx.TM., Advantage.TM., Prefyx.TM. delivery device or any other
delivery device. In some embodiments, the first and second dilators
are small in diameter to provide a less invasive surgery. In some
embodiments, an association loop can be formed, such as with a
thread for an association of the dilators with the delivery device.
The association loop is provided at distal ends of the first
dilator and the second dilator to associate the first dilator and
the second dilator to the delivery device.
As mentioned above, the medical assembly 100 further includes the
tab 108 configured to be coupled to the implant 102. The tab 108 is
configured to identify the mid portion 120 of the implant. In some
embodiments, the tab 108 can be colored for easy visualization
during surgical procedure.
The tab 108 is further provided with a slot to receive the first
elongate member 110, the second elongate member 112, and the third
elongate member 114. In certain embodiments, the first elongate
member 110 is configured to removably couple the implant 102 with
the first sleeve 104 such that the first elongate member 110
extends from the first portion 116 to the mid portion 120 of the
implant 102 and past the mid portion 120 and exits the implant 102
through the mid portion 120. The second elongate member 112 is
configured to removably couple the implant 102 with the second
sleeve 106 such that the second elongate member 112 extends from
the second portion 118 to the mid portion 120 of the implant 102
and past the mid portion 120 and exits the implant 102 through the
mid portion 120. The first elongate member 110 and the second
elongate member 112 are coupled together at the tab 108 to form a
first knot at the tab 108 or in close proximity of the tab 108. The
first knot not only couples the tab 108 to the first elongate
member 110 and the second elongate member 112, but also the first
elongate member 110 and the second elongate member 112 to each
other at the tab. The first knot can be considered as a junction
where the first elongate member 110, the second elongate member 112
and the tab 108 are contacted or coupled. In some embodiments, the
first elongate member 110, second elongate member 112, and the
third elongate member can be a rope, suture, filament, thread, and
the like.
In some embodiments, the tab 108 may include multiple slots to
receive the first elongate member 110, the second elongate member
112, and the third elongate member 114. In some other embodiments,
the first elongate member 110 and the second elongate member 112
may be coupled to the tab 108 through various coupling mechanisms
and fasteners instead of directly tying them and forming knots. In
such embodiments, various coupling mechanism and fasteners such as
staples, glue, heat bonding, pins, and the like may be used.
The tab 108 may be made of any material known in the art, such as,
for example, polyethylene, PTFE, or EPTFE, and may be of any color,
such as blue, to assist the user in viewing the tab 108. The tab
108 may be sized and otherwise configured to assist in positioning
a portion of the implant 102 and/or the sleeves 104 and 106 within
the body of a patient.
In some embodiments, the first elongate member 110 and the second
elongate member 112 include one of a thread, a medical suture, a
filament, a rope, and the like. In some embodiments, the first
elongate member 110 and the second elongate member 112 have a
single suture or thread running along the maximum of half of the
total length 122 of the implant 102. In some other embodiments, the
first elongate member 110 and the second elongate member 112 have
multiple sutures or threads running along the maximum of half of
the total length 122 of the implant 102. For example, multiple
sutures or threads may be provided for coupling the implant 102
with the sleeves 104 and 106 such that the sutures or threads are
placed adjacent to one another for increasing strength of the
coupling.
In some embodiments, the first elongate member 110 and the second
elongate member 112 couple the implant 102 with the first sleeve
104 and the second sleeve 106 respectively in a manner that the
first elongate member 110 and the second elongate member 112 are
threaded in and out through the implant 102. Each of the first
elongate member 110 and the second elongate member 112 first passes
from the first surface of the implant 102 to the second surface and
then from second surface to the first surface, thereby forming one
stitch. Similarly, this pattern of stitches continues to a certain
length of the implant 102 to form multiple stitches in a sequence
that may be termed as a running stitch. The running stitch thus
refers to a series of stitches that hold the sleeves 104 and 106
and the implant 102 through frictional resistance together. The
elongate members 110 and 112 are threaded in and out of the implant
102 and the sleeves 104 and 106 in a manner that the frictional
resistance is reached to an extent where suture can keep the
sleeves 104 and 106 and the implant 102 coupled together but may
allow decoupling of the implant 102 and the sleeves 104 and 106
when the elongate members 110 and 112 are pulled by overcoming the
frictional resistance. The stitches may be of varying length, or
same length. In accordance with some embodiments, the running
stitch may be in the form of a straight line orientation relative
to a direction of pull to facilitate removal of the elongate
members 110 and 112. In some embodiments, the running stitch may be
in the form of a curve or a zigzag pattern instead of a straight
line orientation.
In some embodiments, the first elongate member 110 and the second
elongate member 112 may have one free end. In certain other
embodiments, the first elongate member 110 and the second elongate
member 112 may have no free ends such that one end is tied to the
tab 108 and the other end is tucked into the sleeves 104 and 106.
In certain embodiments, both the first elongate member 110 and the
second elongate member 112 may have a free end.
The medical assembly 100 further includes the third elongate member
114 configured to pass through the mid portion 120 of the implant
102 and form a loop such that the loop couples the mid portion 120
of the implant 102 with the tab 108. In some embodiments, the third
elongate member 114 is a thread or a suture and the like, which is
a part separate from the implant 102 to be removably coupled to the
implant and the tab 108 for coupling the tab 108 with the implant
102 through the loop. In other embodiments, the third elongate
member 114 can be an integral part of the implant 102 such that the
third elongate member 114 is weaved into the implant 102 center and
extend from there outside the implant 102 to form the loop that is
configured to receive the tab 108 for coupling the tab 108 with the
implant 102. The third elongate member 114 is threaded through the
mid portion 120 of the implant 102 such that the third elongate
member 114 passes through the implant 102 at the mid portion 120
and then form a loop type of structure. In some embodiments, free
ends of the third elongate member 114 can be tied together to form
a knot referred to as a second knot. In accordance with these
embodiments, the third elongate member 114 first passes through the
implant mid portion 120 and then through a slot in the tab 108 and
then knotted together to couple the tab 108 with the implant 102.
This pattern of association of the implant 102 with the tab 108 is
configured to disassociate the implant 102 from the tab 108 by
cutting the third elongate member 114 or removing the second knot.
In certain embodiments, cutting the third elongate member 114 and a
mere pulling of the tab 108 is configured to release the first
sleeve 104 and the second sleeve 106 from the implant 102.
In accordance with the embodiments described above, the tab 108 is
therefore coupled to the third elongate member 114 directly through
the second knot, and also to the first elongate member 110 and the
second elongate member 112 through the first knot formed at the tab
108. The first knot not only couples the tab 108 to the first
elongate member 110 and the second elongate member 112,
respectively, but also the first elongate member 110 and the second
elongate member 112 to each other at the tab. Therefore, the first
elongate member 110 and the second elongate member 112 are together
configured to be removed when the tab 108 is pulled after cutting
the second knot formed at the tab 108 by the third elongate member
114. In some embodiments, the first elongate member 110 and the
second elongate member 112 can be removed by cutting the third
elongate member 114 at a location other than the second knot.
In accordance with an embodiment, the first elongate member 110 can
be configured to extend from the first dilator to the implant 102
and the first sleeve 104 such that the first elongate member 110
extends externally at some portion of the implant 102 and the first
sleeve 104, and pierces through and extends within the first sleeve
104 and the implant 102 at some other portion. In accordance with
these embodiments of threading, the first elongate member 110 may
extend from the dilator to and along the first sleeve 104 and the
first portion of the implant 102 and then may traverse back toward
the first dilator thereby forming a loop shape. In an embodiment,
the first elongate member 110 may be configured to couple the first
dilator. In an embodiment the first elongate member 110 may couple
the first dilator and then extend along a lumen of the first
dilator and extend out of the lumen of the first dilator such that
the first elongate member 110 can be configured to be removed by a
mere pulling of an extended portion extending out of the lumen of
the first dilator. In an embodiment, the first sleeve 104, or the
first sleeve 104 and the implant 102 can include one or more holes
that facilitate extension of the first elongate member 110 along
the first sleeve 104 and the implant 102.
In an embodiment, a portion of the first elongate member 110 is
configured to provide slack or a slack portion in the first
elongate member 110 and the slack portion is accessible to an
operator such that the operator can cut the slack portion to
decouple the first sleeve 104 from the first portion of the implant
102.
In accordance with an embodiment, the second elongate member 112
can be configured to extend from the second dilator to the implant
102 and the second sleeve 106 such that the second elongate member
112 extends externally at some portion of the implant 102 and the
second sleeve 106, and pierces through and extends within the
second sleeve 106 and the implant 102 at some other portion. In
accordance with these embodiments of threading, the second elongate
member 112 may extend from the second dilator to and along the
second sleeve 106 and the second portion of the implant 102 and
then may traverse back toward the second dilator thereby forming a
loop shape. In an embodiment, the second elongate member 112 may be
configured to couple the second dilator. In an embodiment the
second elongate member 112 may couple the second dilator and then
extend along a lumen of the second dilator and extend out of the
lumen of the second dilator such that the second elongate member
112 can be configured to be removed by a mere pulling of an
extended portion extending out of the lumen of the second dilator.
In an embodiment, the second sleeve 106, or the second sleeve 106
and the implant 102 can include one or more holes that facilitate
extension of the second elongate member 112 along the second sleeve
106 and the implant 102.
In an embodiment, a portion of the second elongate member 112 is
configured to provide a slack in the second elongate member 112 and
the slack portion is accessible to an operator such that the
operator can cut the slack portion to decouple the second sleeve
106 from the second portion of the implant 102.
In accordance with some embodiments, the first elongate member 110,
the second elongate member 112, and the third elongate member 114
can be configured in a single piece of thread.
In some embodiments, the color of the first elongate member 110,
the second elongate member 112, and the third elongate member 114
are different. In some embodiments, the color of the first elongate
member 110 and the second elongate member 112 is same, which is
distinct from the color of the third elongate member 114. This
helps in easy distinction between the first and second elongate
members 110 and 112, and the third elongate member 114, especially
when the third elongate member 114 is cut for removal and
disengagement of sleeves 110 and 112 as described below in
conjunction with FIG. 8. In some other embodiments, the color of
all the elongate members 110, 112, and 114 may however be kept the
same, and the physician or the doctor may distinguish between the
third elongate member 114 and the first and second elongate members
110 and 112 based on his perception of visual feedback or
experience.
In accordance with the embodiments described above, the sleeves 104
and 106 are coupled to the implant 102 with two elongate
members--the first elongate member 110 and the second elongate
member 114. In some other embodiments, however, the implant 102 can
be coupled to the sleeves 104 and 106 through a single elongate
member that may be referred to as an elongate member for simplicity
of description. In these embodiments, the elongate member is
configured to removably couple the implant 102 with the first
sleeve 104 and the second sleeve 106. The elongate member extends
from the first portion 116 to the mid portion 120 of the implant
102 and past the mid portion 120 such that the elongate member
exits the implant 102 through the mid portion 120 and forms a loop
near the mid portion 120. The elongate member is further configured
to enter the implant 102 through the mid portion 120 and extend
from the mid portion 120 to the second portion 118 of the implant
102.
The elongate member extends from the first portion 116 of the
implant 102 such that the elongate member is threaded in from the
first surface of the implant 102 to the second surface of the
implant 102 and then threaded out from the second surface to the
first surface of the implant 102 and further threaded in from first
surface to the second surface of the implant 102 and so on such
that the elongate member forms a running stitch similar to the
running stitch as described above. The single elongate member is
used to couple the first sleeve 104 and the second sleeve 106 with
the implant 102. In accordance with some embodiments, the single
elongate member may extend from the first portion 116 to the mid
portion 120 and then exit out from the implant 102 to extend and
exit through the tab 108 and form a loop near and around the tab
108. The elongate member 110 then extends from the tab 108 to the
second portion 118. In this manner, the single elongate member
extends from the first portion 116 through the tab 108 and to the
second portion 118 of implant 102. Further, in these embodiments,
another elongate member similar to the third elongate member 114 as
described above may be used to couple the implant 102 with the tab
108. However, in still some embodiments, the implant 102 may not be
separately coupled to the tab 108 through the separate third
elongate member 114.
The above described embodiments utilize the tab in the medical
assembly. However, in some cases the medical assembly may not
include any tab. In such cases, the first elongate member 110 and
the second elongate member 112 (in case of multiple elongate
members) or the elongate member (if there is only one elongate
member) are configured to exit the mid portion 120 of the implant
102 and form a loop or a knot kind of structure around or close to
the mid portion 120 without any requirement of the tab 108. The
first elongate member 110 and the second elongate member 112 or the
elongate member (if there is only one elongate member) can be
removed just by pulling them at the loop.
In accordance with some embodiments, the single elongate member
that couples the sleeves 104 and 106 with the implant 102, and the
third elongate member can be configured in a single piece of
thread.
In accordance with some embodiments, a carrier, dart, or an anchor
or a combination thereof can be incorporated in the medical
assembly 100.
In accordance with some embodiments, the medical assembly 100 can
be used to treat incontinence.
FIG. 2A is a perspective view of a medical assembly 200 in
accordance with an embodiment of the present invention.
The medical assembly 200 includes an implant 202, a first sleeve
204, a second sleeve 206, a tab 208, a first elongate member 210, a
second elongate member 212 and a third elongate member 214.
The implant 202 has a first portion 216, a second portion 218 and a
mid portion 220 between the first portion 216 and the second
portion 218. In some embodiments, the mid portion 220 of the
implant 202 is de-tanged (without tangs). The length of the
de-tanged section can vary based on surgical requirements or
location of placement inside the patient's body. In some
embodiments, the first portion 216 and the second portion 218 may
include tangs such that upon placement of the implant 202, the
first portion 216 and the second portion 218 of the implant can
interact with bodily tissues. The implant 202 can be formed from
various materials such as polymeric material as described above in
conjunction with FIG. 1.
The medical assembly 200 as illustrated in FIG. 2A further includes
the first sleeve 204 and the second sleeve 206 configured to shield
the first portion 216 and the second portion 218 of the implant
202. In some embodiments, the first sleeve 204 and the second
sleeve 206 can be thin wall flat tubes. In some embodiments, the
first sleeve 204 and the second sleeve 206 are made of polymer and
may be colored blue for easy visualization. In other embodiments,
the first sleeve 204 and the second sleeve 206 can be manufactured
from an opaque or a transparent plastic film. The transparent
plastic film enables visual examination of the implant 202. The
first sleeve 204 and the second sleeve 206 be single or multiple
ply. The first sleeve 204 and the second sleeve 206 can be made by
extrusion or sandwiching two sheets of polymer together.
Each of the first sleeve 204 and the second sleeve 206 includes a
proximal end portion 222 and 224 and a distal end portion 226 and
228 with a length 230 and 232 extending between the proximal end
portion 222 and 224 and the distal end portion 226 and 228 such
that the length 230 of the first sleeve 204 is sufficient to
envelop or shield the first portion 216 of the implant 202 and
length 232 of the second sleeve 206 is sufficient to shield the
second portion 218 of the implant 202. In various embodiments, the
first portion 216 is a first end portion of the implant 202 and the
second portion 218 is the second end portion of the implant 202
such that the first sleeve 204 and the second sleeve 206 are
configured to enclose the first end portion and the second end
portion respectively of the implant 202. The first sleeve 204 and
the second sleeve 106 are together hereafter referred to as sleeves
204 and 206 for simplicity of the description.
In some embodiments, the sleeves 204 and 206 can have a variety of
shapes. For example, the sleeves 204 and 206 can be rectangular
with a tapered proximal end portion and the distal end portion 226
and 228 such that the sleeves 204 and 206 can be easily withdrawn
without catching a tissue. In some embodiments, the sleeves 204 and
206 are shaped in the form of hollow tubes or envelopes such that a
hollow space within the sleeves 204 and 206 define lumen 240 and
242 therein. The lumen 240 and 242 of the sleeves 204 and 206 is
configured to receive first portion 216 and the second portion 218
which are the first end portion and the second end portion of the
implant 202. The first end portion and the second end portion may
be respectively disposed within the lumen 240 and 242 of the first
sleeve 204 and the second sleeve 206. In some embodiments, the
implant 202 may be free-floating within the first sleeve 204 and
the second sleeve 206. Alternatively, the implant 202 may be fixed
to the sleeves 204 and 206.
In some embodiments, the lumen 240 and 242 of the sleeves 204 and
206 have width 246 and 248 which is larger than width of the
implant 202 at the first and the second end portion that are
configured to be covered by the sleeves 204 and 206. This allows
housing of the end portions 216 and 218 of the implant 202 within
the lumen 240 and 242 of the sleeves 204 and 206. In some other
embodiments, the proximal end portions 222 and 224 of the sleeves
204 and 206 are slightly tapered to allow easy withdrawal without
catching tissues. In some embodiments, the sleeves 204 and 206 can
be made of resilient or flexible material such that the width of
the lumen 240 and 242 is smaller than the width of the implant 202
in a normal condition. However, since the sleeve 204 and 206 is
configured to be stretched due to its flexible material, the width
of the lumen 240 and 242 can be increased to an extent that makes
the receipt of the implant 202 possible within the lumen 240 and
242.
In certain embodiments of the present invention, the first and the
second sleeves 204 and 206 shield only the first portion 216 and
the second portion 218 the implant 202 such that the mid portion
220 of the implant 202 remains un-shielded. The un-shielded mid
portion 220 is configured to interact to a bodily tissue upon
placement. In certain other embodiments, the first sleeve 204 and
the second sleeve 206 together encloses a maximum of half of a
total length of the implant 202, thus shielding half of the implant
202 and leaving the other half of the implant 202 un-shielded. In
some embodiments, the first sleeve 204 and the second sleeve 206
together encloses less than half of the total length of the implant
202. In some other embodiments, the first sleeve 204 and the second
sleeve 206 together encloses half of the total length of the
implant 202. In some other embodiments, the first sleeve 204 and
the second sleeve 206 together encloses about half of the total
length of the implant 202. In some other embodiments, the first
sleeve 204 and the second sleeve 206 may together enclose slightly
or substantially more than half of the total length of the implant
202. In some embodiments, the length of the implant 202 that is
shielded with the sleeves 204 and 206 can vary based on
requirements.
In some embodiments, for example, as shown in FIG. 2B, the implant
202 has an initial length of 28 cm and portions of the implant 202
at its ends are folded over to create a working length of 27 cm. In
some embodiments, the folds can be secured to the implant 202 by a
suture, tack, or the like fasteners. The working length can be
created by folding a length of 0.5 cm on each side of the implant
202. The folded length can be 0.5 cm, 1 cm, 2 cm or any preferred
length to increase the holding strength of the sling via tangs, in
accordance with various other embodiments. In some embodiments, the
fold is secured to the implant 202 by a suture, tack or the like
elements or fasteners. A working length of about 27 cm would
maintain the entire length of the sling within a patient and
require no trimming after placement, in accordance with some
embodiments. For a 27 cm working length of the implant 202, 25%
maximum of the implant 202 is covered with the sleeves 204 and 206
or 6.75 cm maximum of each of the implant 202 ends are covered, in
accordance with some embodiments of the present invention. In
accordance with some embodiments, exemplary dimensions of some
portions or components of the medical assembly 200 are shown in
FIG. 2C. It must be appreciated that various other dimensions of
these portions and components of the medical assembly 200 can be
possible.
Referring again to FIG. 2A, in certain embodiments of the present
invention, the medical assembly 200 may also include a first
dilator 252 configured to be coupled to the first sleeve 204, and a
second dilator 254 configured to be coupled to the second sleeve
206. The first dilator 252 and the second dilator 254 are
configured to be coupled respectively to the distal end 226 and 228
of the first sleeve 204 and the second sleeve 206. The first
dilator 252 and the second dilator 254 are heat bonded respectively
to the first sleeve 204 and the second sleeve 206. In some
embodiments, the first dilator 252 and the second dilator 254 are
further configured to be coupled to a delivery device 262, as shown
in FIG. 2D. The delivery device 262 is a medical instrument that
can be used to facilitate delivery of the medical assembly 200
including the implant 202 within the patient's body. A few examples
of the delivery devices may include the Boston Scientific
Corporation Obtryx.TM., Lynx.TM., Advantage.TM., Prefyx.TM.
delivery device or any other delivery device. In some embodiments,
the dilator is small in diameter to provide a less invasive
surgery. The dilator can be further associated with an association
skive. An exemplary association skive is shown in FIG. 5 later.
As mentioned above, the medical assembly 200 further includes the
tab 208 configured to be coupled to the implant 202. The tab 208 is
configured to identify the mid portion 220 of the implant 202 and
provide for equal length of the implant 202 on each side of a body
tissue or organ required to be balanced such as a urethra of the
patient. In some embodiments, the tab 208 can be colored for easy
visualization during a surgical procedure.
The tab 208 is further provided with a slot 256 to receive the
first elongate member 210, the second elongate member 212 and the
third elongate member 214. In certain embodiments, the first
elongate member 210 is configured to removably couple the implant
202 with the first sleeve 204 such that the first elongate member
210 extends from the first portion 216 to the mid portion 220 of
the implant 202 and past the mid portion 220 and exits the implant
202 through the mid portion 220. The second elongate member 212 is
configured to removably couple the implant 202 with the second
sleeve 206 such that the second elongate member 212 extends from
the second portion 218 to the mid portion 220 of the implant 202
and past the mid portion 220 and exits the implant 202 through the
mid portion 220. The first elongate member 210 and the second
elongate member 212 are coupled together at the tab 208 or in close
proximity of the tab 208.
In some other embodiments, the tab 208 may include only a single
slot 256 to receive all of the three elongate members--the first
elongate member 210, the second elongate member 212, and the third
elongate member 214.
In some embodiments, the tab 208 may include multiple slots to
receive the first elongate member 210, the second elongate member
212, and the third elongate member 214 as shown in FIG. 2E. As
illustrated in FIG. 2E, the medical assembly 200 includes two slots
to receive the first elongate member 210, the second elongate
member 212, and the third elongate member 214. A first slot 264 is
configured to receive the first elongate member 210 and the second
elongate member 212 whereas the second slot 266 is configured to
receive the third elongate member 214. The first elongate member
210 and the second elongate member 212 are coupled together at the
tab 208 to form a first knot 268 at the tab 208 or in close
proximity of the tab 208. The first knot 268 not only couples the
tab 208 to the first elongate member 210 and the second elongate
member 212, but also the first elongate member 210 and the second
elongate member 212 to each other at the tab. The first knot 268
can be considered as a junction where the first elongate member
210, the second elongate member 212 and the tab 208 are contacted
or coupled. The third elongate member 214 forms a second knot 270
at the tab 208.
The tab 208 may be made of any material known in the art, such as,
for example, polyethylene, PTFE, or EPTFE, and may be of any color,
such as blue, to assist the user in viewing the tab 208. The tab
208 may be sized and otherwise configured to assist in positioning
a portion of the implant 202 and/or the sleeves 204 and 206 within
the body of a patient.
The first elongate member 210 and the second elongate member 212
include one of a thread, a medical suture, a filament, a rope, and
the like. In some embodiments, as shown in FIG. 2A, the first
elongate member 210 and the second elongate member 212 have a
single suture or thread running along a portion of length of the
implant 202. However, in some other embodiments, the first elongate
member 210 and the second elongate member 212 may have multiple
sutures or threads running along a portion of length of the implant
202 as shown in FIG. 2F. For example, the first elongate member 210
may have multiple sutures or threads such as 210a and 210b that may
be provided for coupling the implant 202 with the sleeves 204 and
206 such that the sutures or threads are placed adjacent to one
another for increasing strength of the coupling. In some
embodiments, the first elongate member 210 including the sutures or
threads 210a and 210b extends from the first portion 216 to the mid
portion 220 of the implant 202 such that the sutures or threads
210a and 210b exit the implant 202 at mid portion 220. Similarly,
the second elongate member 212 including the sutures or threads
212a and 212b extends from the second portion 218 to the mid
portion 220 of the implant 202 such that the sutures or threads
212a and 212b exit the implant 202 at mid portion 220. After
exiting the implant 202, the free ends of the sutures or threads
210a and 210b, 212a, and 212b are tied together to form a knot that
is configured to be coupled with the tab 208. In some other
embodiments, the third elongate member 214 passes through the mid
portion 220 of the implant 202 and couples with the tab 208 such
that cutting the third elongate member 214 leaves the tab 208 still
coupled with the implant 202. The tab 208 is coupled with the
implant 202 through the first elongate members 210 and the second
elongate member 212.
Referring again to FIG. 2A, in some embodiments, the first elongate
member 210 and the second elongate member 212 couple the implant
202 with the first sleeve 204 and the second sleeve 206
respectively in a manner that the first elongate member 210 and the
second elongate member 212 are threaded in and out through the
implant 202. Each of the first elongate member 210 and the second
elongate member 212 first passes from the first surface 276 of the
implant 202 to the second surface 278 and then from second surface
to the first surface 276, thereby forming one stitch. Similarly,
this pattern of stitches continues to a certain length of the
implant 202 to form multiple stitches in a sequence that may be
termed as a running stitch. The running stitch thus refers to a
series of stitches that hold the sleeves 204 and 206 and the
implant 202 through frictional resistance together. This has been
described in conjunction with FIG. 1. The elongate members 212 are
threaded in and out of the implant 202 and sleeves 204 and 206 in a
manner that the frictional resistance is reached to an extent where
the elongate members can keep the sleeves 204 and 206 and the
implant 202 coupled together but may allow decoupling of the
implant 202 and the sleeves 204 and 206 when the elongate members
are pulled by overcoming the frictional resistance. In certain
embodiments, the first elongate member 210 and the second elongate
member 212 may have no free ends such that one end is tied to the
tab 208 and the other end is tucked into the sleeves 204 and 206.
In some embodiments, the first elongate member 210 and the second
elongate member 212 may have one free end such that one end is tied
to the tab 208 and the other end is free. The free end may further
extend from end portions of the implant 202 beyond the dilators 252
and 254 to form association loops 272 and 274 as illustrated in
FIG. 2G. The association loops 272 and 274 are configured to
provide an association with the delivery device. In some
embodiments, the association loop can associate the delivery device
with an L shape slot or a reverse L shape slot.
As mentioned above, the medical assembly 200 includes the third
elongate member 214 configured to pass through the mid portion 220
of the implant 202 and form a loop 260 such that the loop 260
couples the mid portion 220 of the implant 202 with the tab 208. In
some embodiments, the third elongate member 214 is a thread or a
suture and the like that is a part separate from the implant 202 to
be removably coupled to the implant 202 and the tab 208 for
coupling the tab 208 with the implant 202 through the loop 260. In
other embodiments, the third elongate member 214 can be an integral
part of the implant 202 such that the third elongate member 214 is
weaved into the implant 202 center and extend from there outside
the implant 202 to form the loop 260 that is configured to receive
the tab 208 for coupling the tab 208 with the implant 202. The
third elongate member 214 is threaded in and out through the mid
portion 220 of the implant 202 such that the third elongate member
214 passes through the implant 202 at the mid portion 220 and then
form a loop type of structure 260. In some embodiments, free ends
of the third elongate member 214 can be tied together to form a
knot referred to as a second knot 270 as shown in FIG. 2E. In
accordance with these embodiments, the third elongate member 214
first passes through the implant mid portion 220 and then through a
slot 256 in the tab 208 and then knotted together to couple the tab
208 with the implant 202. This pattern of association of the
implant 202 with the tab 208 is configured to disassociate the
implant 202 from the tab 208 by cutting the third elongate member
214 or removing the second knot 270.
In accordance with the embodiments described above, the tab 208 is
therefore coupled to the third elongate member 214 directly through
the second knot 270 and also to the first elongate member 210 and
the second elongate member 212 through the first knot 268 as shown
in FIG. 2E formed at the tab 208. The first knot 268 not only
couples the tab 208 respectively to the first elongate member 210
and the second elongate member 212 but also the first elongate
member 210 and the second elongate member 212 to each other at the
tab. Therefore, the first knot 268 holds the first and the second
elongate members 210 and 212 also together. Therefore, the first
elongate member 210 and the second elongate member 212 are together
configured to be removed when the tab 208 is pulled after cutting
the second knot 270 formed at the tab 208 by the third elongate
member 214. In some embodiments, the first elongate member 210 and
the second elongate member 212 can be removed by cutting the third
elongate member 214 at a location other than the second knot
270.
In some embodiments, the color of the first elongate member 210,
the second elongate member 212, and the third elongate member 214
is different. In some embodiments, the color of the first elongate
member 210 and the second elongate member 212 is same which is
distinct from the color of the third elongate member 214 this helps
in easy distinction between the first and second elongate members
210 and 212, and the third elongate member 214 especially when the
third elongate member 214 is cut for sleeves 204 and 206 removal
and disengagement, as described below in conjunction with FIG. 7.
In some other embodiments, the color of all the elongate members
210, 212, and 214 may however be kept same, and the physician or
the doctor may distinguish between the third elongate member 214
and the first and second elongate members 210 and 212 based on his
perception of visual feedback or experience. FIG. 2H illustrates an
enlarged view of the medical assembly 200 shown in FIG. 2A. FIG. 2I
is a cross-sectional side view of the medical assembly 200
illustrated in FIG. 2A.
FIG. 2J illustrates the medical assembly 200 without the tab 208.
As illustrated in FIG. 2J, the medical assembly 200 includes the
implant 202 having the first portion 216, the second portion 218
and the mid portion 220. The medical assembly 200 further includes
the first sleeve 204 and the second sleeve 206. The first sleeve
204 and the second sleeve 206 are configured to be removably
coupled to the implant 202 with a single elongate member 280. In
accordance with some embodiments, the sleeves 204 and 206 are
coupled to the implant 202 using a single elongate member 280 only
that can be referred to as the elongate member 280, as shown in
FIG. 2J.
The single elongate member 280 extends from the first portion 216
to the mid portion 220 of the implant 202 and past the mid portion
220 such that the elongate member 280 exits the implant 202 through
the mid portion 220 and forms a loop 282 near the mid portion 220.
The elongate member 280 further configured to enter the implant 202
through the mid portion 220 and extends from the mid portion 220 to
the second portion 218 of the implant 202.
The elongate member 280 extends from first portion 216 of the
implant 202 such that the elongate member is threaded in from the
first surface 276 of the implant 202 to the second surface 280 of
the implant 202 and then threaded out from the second surface 278
to the first surface 276 of the implant 202 and further threaded in
from first surface 276 to the second surface 278 of the implant 202
and so on such that the elongate member 280 forms a running stitch
across a portion of the implant 202. The single elongate member 280
couples the first sleeve 204 with the implant 202 and extends from
first portion 216 to the mid portion 220 of the implant 202. At the
mid portion 220 of the implant 202 the single elongate member 280
exits the implant 202 and forms a loop 282 near the mid portion
220. After forming the loop 282 the elongate member enters the
implant 202 at the mid portion 220 and extends from the mid portion
220 to the second portion 218 of the implant 202 thereby coupling
the second sleeve 206. Further, as shown in FIG. 2J, both the ends
of the single elongate member 280 may be free such that pulling
either of the ends of the single elongate member 280 decouples the
first sleeve 204 and the second sleeve 206 from the implant 202. In
some embodiments, the first sleeve 204 and the second sleeve 206
are configured to be decoupled by pulling the loop 282 formed near
the mid portion of the implant 202.
FIG. 3A is a perspective view of a medical assembly 300. In some
embodiments, the medical assembly 300 includes an implant 302, a
sleeve 304, and an elongate member 306. The implant 302 has a first
portion 308, a second portion 310 and a mid portion 312 between the
first portion 308 and the second portion 310. The implant 302 can
be similar to the implants described above in conjunction with
various figures.
In some embodiments, the sleeve 304 as shown in FIG. 3A includes a
top layer 314, a bottom layer 316, and a lumen 318 defined between
the top layer 314 and the bottom layer 316. In some embodiments, a
first hole 320 is provided on the top layer 314 and a second hole
322 is provided on the bottom layer 316. The first hole 320 and the
second hole 322 are respectively defined along a thickness 324 of
the top layer 314 and the bottom layer 316.
In some embodiments, the sleeve 304 is a first sleeve 304
configured to be coupled to the first portion 308 of the implant
302. In some other embodiments, the medical assembly 300 includes a
second sleeve 326 similar to the first sleeve 304 such that the
second sleeve 326 is configured to be coupled to the second portion
310 of the implant 302. In some embodiments, both the first sleeve
304 and the second sleeve 326 cover around 60% of a length 328 of
the implant 302. Then second sleeve 326 may also include a first
hole 366 and a second hole 368 similar to the holes 320 and 322 in
the first sleeve 304.
In some embodiments, the elongate member 306 is configured to pass
through the first hole 320, along the lumen 318 and the second hole
322 and couples the implant 302 with the sleeve 304. In some
embodiments, the elongate member 306 is a first elongate member 306
configured to removably couple the first portion 308 of the implant
302 with the first sleeve 304. In some embodiments, the medical
assembly 300 also includes a second elongate member 330 similar to
the first elongate member 306 that is configured to pass through
holes in the second sleeve 326.
As illustrated in FIG. 3A, the first elongate member 306 extends
from a distal end portion 332 of the first sleeve 304 to the first
portion 308 of the implant 302 thereby coupling the first portion
308 of the implant 302 with the first sleeve 304. The first
elongate member 306 extends in and out across the first sleeve 304
through the first hole 320 on the top layer 314 along the lumen 318
of the first sleeve 304, and further through the second hole 322 on
the bottom layer 316 of the first sleeve 304.
In some embodiments, the implant 302 can be a mesh based device
such that the first elongate member 306 passes through a mesh cell
of the implant 302. In some embodiments, the implant 302 can be a
non-mesh based device such that the non-mesh based device includes
a hole (not shown) that is configured to facilitate passing of the
first elongate member 306 through the implant 302.
In some embodiments, the second elongate member 330 extends from
the distal end portion 334 of the second sleeve 326 to the second
portion 310 of the implant 302 and extends across the first hole
366 of the top layer 358 and the second hole 368 of the bottom
layer 360 of the second sleeve 326 thereby coupling the second
portion 310 of the implant 302 with the second sleeve 326 in a
manner similar to the first elongate member 306. In accordance with
some embodiments, the first sleeve 304 and the second sleeve 326
may include at least one hole similar to the holes 320 and 322. In
case of multiple holes, the first elongate member 306 and the
second elongate member 330 should pass through at least one hole in
the respective sleeves 304 and 326.
In some embodiments, the first elongate member 306 can be oriented
linearly and centered along the length 362 of the first sleeve 304.
Similarly, the second elongate member 326 can be oriented linearly
and centered along the length 364 of the second sleeve 326.
In some embodiments, the first elongate member 306 as shown in FIG.
3B, originates from the distal end portion 332 of the first sleeve
304 and extends to the first hole 320 formed at the top layer 314
of the first sleeve 304 in a manner that the first elongate member
306 includes a portion 336 laid at a surface external to the top
layer 314. The portion 336 is configured to provide a slack in the
first elongate member 306 and is accessible to an operator such
that the operator can cut the exposed portion to decouple the first
sleeve 304 from the first portion 308 of the implant 302. In such
embodiments, at least one portion 336 of the first elongate member
306 is configured to lay external to the top layer 314 or the
bottom layer 316 of the first sleeve 304. The portion 336 can be
referred to as first portion 336 of the first elongate member
306.
As shown in FIG. 3B, the first elongate member 306 is shown to pass
through multiple holes similar to the holes 320 and 322. In some
embodiments, hole 340 may be made in line with hole 322 and holes
338 and 344 may be made in line through top layer 314 and bottom
layer 316. In some embodiments, not all holes are used. In
accordance with the illustrated embodiment of FIG. 3B, the first
elongate member 306 passes through the first hole 320 at the top
layer 314 of the first sleeve 304, and then extends across a
portion within the lumen 318 of the first sleeve 304. The first
elongate member 306 extends from the lumen 318 of the first sleeve
304 to a third hole 338 at the top layer 314 of the first sleeve
304. The first elongate member 306 then extends from the third hole
338 to a fourth hole 340 at the top layer 314 of the first sleeve
304. A second portion 342 of the first elongate member 306 that
lies between the third hole 338 and the fourth hole 340 is external
to the top layer 314 and is accessible to the operator. The second
exposed portion 342 of the first elongate member 306 is configured
to provide a slack. The slack provided by the first portion 336 and
the second portion 342 enables an operator to pull or cut the first
elongate member 306 to decouple the first sleeve 304 from the
implant 302 without cutting the first sleeve 304. The first
elongate member 306 then passes from the fourth hole 340 at the top
layer 314 of the first sleeve 304 to the first portion 308 of the
implant 302 and further through the second hole 322 at the bottom
layer 316 of the first sleeve 304. The first elongate member 306
then extends from the second hole 322 to a fifth hole 344 of the
bottom layer 316 of the first sleeve 304. A third portion 346 of
the first elongate member 306 between the second hole 322 and the
fifth hole 344 of the bottom layer 316 of the first sleeve 304 is
exposed and is accessible to the operator (for example, if the
medical device extends through the skin incision). The first
elongate member 306 then moves from the fifth hole 344 into the
lumen 318 of the first sleeve 304 and extends to the distal end
portion 332 of the first sleeve 304. In this manner, the first
elongate member 306 couples the first sleeve 304 and the first
portion 308 of the implant 302 together. Both free ends of the
first elongate member 306 lying at the distal end portion 332 of
the first sleeve 304 can be further coupled with a first dilator
348. The free ends of the first elongate member 306 can be coupled
to the first dilator 348 through various coupling elements or
modes. The various coupling elements or modes may include gluing,
stapling, knotting or ultrasonic welding. In some embodiments, an
excess slack at the first portion 336, the second portion 342, the
third portion 346 or along a rest of the portion of the first
elongate member 306 can be removed or adjusted such that the length
of the first elongate member 306 is configured to prevent migration
or dislodgement or movement of the medical assembly 300 or a
portion of the medical assembly 300 during delivery of the implant
302.
In some embodiments, the excess slack, for example, at the first
portion 336 of the first elongate member 306 is cut to release the
implant 302 from the first sleeve 304 thereby resulting in two free
ends of the first elongate member 306. The first dilator 348,
external to the body, is pulled in the direction of arrow A, as
shown in FIG. 3B or away from the body. In an embodiment, the arrow
A can represent a direction along the vaginal opening or vaginal
passageway. In another embodiment, the arrow A can specify a
direction different from a direction of the vaginal opening. In
such examples, the direction of A can be any other bodily opening
or a passageway created through incisions along a body portion such
as skin incisions, groin incisions, midline incisions, incisions in
thigh, buttock or any other bodily location. The dilator 348 is
pulled out through the passageway thus created. In some
embodiments, the dilator 348 can be pulled away from the reminder
of the medical assembly 300 while the dilator 348 is coupled to the
first sleeve 304 and the first elongate member 306. Thus, the
dilator 348, the first elongate member 306, and the first sleeve
304 may be pulled away from the implant 302 together at one time.
In other embodiments, the dilator 348 can be pulled out from while
the one end of the first elongate member 306 is still attached to
the medical assembly 300 and the first elongate member 306 and the
first sleeve 304 may be removed separately from the dilator 348.
The cut free end of the first elongate member 306 unthreads from
the first sleeve 304 and the implant 302 in a path of arrow B, as
shown in FIG. 3B. The path of arrow B is the path travelled by the
first elongate member 306 while unthreading and decoupling the
first sleeve 304 from the implant 302, and removing the first
elongate member 306 or the first dilator 348 from the body. The
first elongate member 306 travels from the top layer 314 to the
bottom layer 316 as the first dilator 348 is pulled in the
direction of arrow A. The first sleeve 306 along with the first
elongate member 306 is removed as a single part through the
passageway that can be the vaginal opening or the skin incision. In
some embodiments, the center tab (not shown) can be removed through
the midline incision. In some embodiments, the first sleeve and the
first elongate member can together be removed from the skin
incisions.
It must be appreciated that threading of the first elongate member
306 with the implant 302 and the first sleeve 304 as discussed
above is exemplary and various other ways may also be possible.
Similarly, the second elongate member 330 can be threaded to couple
the implant 302 with the second sleeve 326.
The first elongate member 306 and the second elongate member 330
can be threaded in various ways through the holes of the top layer
314 and the bottom layer 316 of the first sleeve 304 and the second
sleeve 326. One such variation is illustrated in FIG. 3C, where the
first elongate member 306 originates from the distal end portion
332 and extends from the lumen 318 of the first sleeve 304 to the
first hole 320 of the top layer 314. The first elongate member 306
then extends out from the lumen 318 of the first sleeve 304 through
the first hole 320 and lay exposed external to the top layer 314.
The first elongate member 306 then extends from the first hole 320
directly to the fourth hole 340 and goes inside the lumen 318 again
through the fourth hole 340. The first elongate member 306 then
passes through the first portion 308 of the implant 302 and further
moves out of the lumen 318 of the first sleeve 304 through the
second hole 322 of the bottom layer 316. Further, the first
elongate member 306 extends from the second hole 322 to the fifth
hole 344 and from the fifth hole 344 to the lumen 318 of the first
sleeve 304. The free ends of the first elongate member 306 is then
knotted with and coupled to the first dilator 348. In another
embodiment, as illustrated in FIG. 3D, the device 300D includes an
elongate member 306D. The elongate member 306D extends from the
dilator, through a portion of the implant, through an opening or
hole 340D in the sleeve, and back to the dilator external to the
sleeve. The end portions of the sleeve are coupled to the dilator
and thus, the elongate member forms a loop to couple the dilator to
the implant and the sleeve.
In some embodiments of the present invention, a third elongate
member 350 as shown in FIG. 3A, is configured to pass through the
mid portion 312 of the implant 302 and form a loop such that the
loop is configured to couple the mid portion 312 of the implant 302
with a tab 352. In some embodiments, the third elongate member 350
first passes across a slot 354 of the tab 352 and then through the
mid portion 312 of the implant 302. The third elongate member 350
further exits the implant 302 at the mid portion 312 and passes
again through the slot 354 of the tab 352. Thus, both free ends of
the third elongate member 350 lie near the tab 352. In some
embodiments, the free ends can then form a knot 356 to couple the
mid portion 312 of the implant 302 with the tab 352. In some
embodiments, the third elongate member 350 presses or forces a
portion of the tab 352 against the mid portion 312 of the implant
302.
Referring again to FIGS. 3A-3C, the first sleeve 304 and the
implant 302 can be decoupled by pulling or cutting any of the first
portion 336, the second portion 342 or the third portion 346 of the
first elongate member 306. The first dilator 348 or the first
sleeve 304 can then be pulled in order to remove the first sleeve
304 from the implant 302. The third elongate member 350 can be cut
and the tab pulled by the operator to decouple the tab 352 and
elongate member from the implant 302.
As shown in FIG. 3E the first elongate member 306 is configured to
couple the first sleeve 304 and the first portion 336 of the
implant 302 such that the first portion 336 of the first elongate
member 306 extends along the sleeve and lay external to the sleeve
while the second portion 342 of the first elongate member 306
extends through the lumen 318 of the first sleeve 304 and across
the implant 302, the first elongate member 306 extending between
the first dilator 348 and the first sleeve 304 to form a loop
structure of threading. In such embodiments, the first elongate
member 306 can be configured to extend from the first dilator 348
to the implant 302 and the first sleeve 304 such that the first
elongate member 306 extends externally at some portion of the
implant 302 and the first sleeve 304, and pierces through and
extends within the first sleeve 304 and the implant 302 at some
other portion. In accordance with these embodiments of threading,
the first elongate member 306 may extend from the first dilator to
and along the first sleeve 304 and the first portion 336 of the
implant 302, and then may traverse back toward the first dilator
348 thereby forming a loop shape.
In an embodiment, the first elongate member 306 may be configured
to couple the first dilator 348. In an embodiment, the first
elongate member 306 may couple the first dilator 348 and then
extend along a lumen of the first dilator 348 and extend out of the
lumen to form an association loop 374 (described in more detail
below). In other embodiments, the association loop 374 may be
separate from the first elongate member 306. In such embodiments,
the first elongate member 306 is coupled to the first dilator 348
and the association loop 374 (which may be formed of an elongate
portion of various types of materials, such as suture material or a
metal material) is coupled to the first dilator 348. In some
embodiments, the portion 336 of the first elongate member 306 that
lay external to the first sleeve 304 and configured to provide a
slack is accessible to an operator such that the operator can first
cut the exposed portion to decouple the first sleeve 304 from the
first portion 308 of the implant 302. In such embodiments, after
cutting such as the portion 336, the first elongate member 306 and
the first sleeve 304 are together configured to be pulled out of
the body through skin incisions upon implantation of the implant
302 under urethra without cutting the first sleeve 304.
In some embodiments, the first sleeve 304, or the first sleeve 304
and the implant 302 can include one or more holes that facilitate
extension of the first elongate member 306 along the first sleeve
304 and the implant 302. In some embodiments, the first sleeve 304
wraps around completely and attaches to the first dilator 348. In
some other embodiments, the first sleeve 304 wraps around partially
and attaches to the first dilator 348.
In some embodiments, an association loop can be formed, such as
with a thread for an association of the dilators with a delivery
device as shown in FIG. 3F. The association loop is provided at
distal ends of the first dilator 348 and the second dilator 372 to
associate the first dilator 348 and the second dilator 372 to the
delivery device. The association loops 374 and 376 are configured
to provide an association with the delivery device. In some
embodiments, the association loops 372 and 374 can associate the
delivery device with an L shape slot or a reverse L shape slot such
as a BSC Obtryx Halo, Obtryx Curve or Lynx, after the delivery
needle device has been passed through tissue.
Referring again to FIG. 3E, the medical assembly 300 includes the
second dilator 372 and the second elongate member 330 similar to
the first elongate member 306 and the first dilator 348. The second
elongate member 330 extends from the second dilator 372, across a
portion of the second sleeve 326, along a lumen 376 of the second
sleeve 326, across a portion of the implant 302 and extends back to
the second dilator 372 forming a loop. In an embodiment, the first
dilator 348 and the second dilator 372 are each configured to be
coupled to a delivery device to facilitate delivery of the medical
assembly 300 including the implant 302 within the patient's
body.
In accordance with some embodiments of the invention, the medical
assembly 100, 200 or 300 can be coupled to a needle delivery
device. In an embodiment, the first dilator 348 and the second
dilator 372 can be associated to the needle device before passing
through tissue and can be adapted to fit the BSC Advantage,
Advantage fit, or Prefyx delivery devices. In an embodiment, the
first and second sleeves 304 and 326 are attached to the needle
beforehand. In an embodiment, the needle is inserted through the
body such as through the skin incision and toward the vagina.
FIGS. 3G-3K illustrate an embodiment of the medical assembly 900
according to an embodiment of the invention. FIG. 3G is a top view
of the medical assembly 900. FIG. 3H is a bottom view of the
medical assembly 900. FIGS. 3I-3K are perspective views of portions
of the medical assembly 900. FIG. 3L is a schematic view of an
implant 902 of the medical assembly 900 disposed within a body of a
patient.
The medical assembly includes an implant 902, a first sleeve 910, a
second sleeve 912, a first dilator 920, and a second dilator 922.
In some embodiments, the implant 902 is formed of a mesh material
and is configured to be placed into a body of a patient and provide
support to a portion of the body of the patient. For example, in
some embodiments, the implant 902 is configured to be placed in a
pelvic region of a patient and provide support to a pelvic organ,
such as a bladder or a bladder neck, of a patient.
A first end portion of the first sleeve 910 is coupled to the
implant 902 and a second end portion of the first sleeve 910 is
coupled to the dilator 920. Similarly, a first end portion of the
second sleeve 912 is coupled to the implant 902 and a second end
portion of the sleeve 912 is coupled to the dilator 922. In some
embodiments, the sleeves 910 and 912 do not collectively cover the
entire length of the implant 902. For example, in some embodiments,
the sleeves 910 and 912 collectively cover about 50% of the length
of the implant 902. In other embodiments, the sleeves 910 and 912
collectively cover more than 50% of the length of the implant 902.
In some embodiments, the sleeves 910 and 912 are configured to help
facilitate the movement of the medical assembly 900 within the body
of the patient. In some embodiments, the implant 902 includes tangs
or tang members along and edge portion. In some embodiments, the
tangs or tang members are disposed on the portions of the implant
902 that are within the sleeves 910 and 912.
In the illustrated embodiment, the couplings of the sleeves 910 and
912 to the implant 902 are functional and structurally similar.
Accordingly, only the coupling of the second sleeve 912 to the
implant 902 will be discussed in detail. Additionally, in the
illustrated embodiment, the couplings of the sleeves 910 and 912 to
the dilators 920 and 922 are structurally and functionally similar.
Accordingly, only the coupling of the second sleeve 912 to the
dilator 922 will be discussed in detail.
As best illustrated in FIG. 3K, the second sleeve 912 defines a
cavity or lumen 911 and is coupled to a second end portion 901 of
the implant 902. In the illustrated embodiment, a portion of the
second end portion 901 of the implant 902 is disposed within the
cavity or lumen 911 defined by the second sleeve 912.
The second sleeve 912 is removably coupled to the implant 902 by an
elongate member or a suture 942. The suture 942 is coupled to the
dilator 922 and extends or is threaded through the implant 902. As
best illustrated in FIG. 3G, a top portion or surface 913 of the
sleeve 912 defines 4 openings or holes 921, 923, 925, and 927 that
communicate with the lumen 911 defined by the second sleeve 912.
The suture 942 extends from the dilator 922 into the lumen 911
defined by the sleeve 912 and extends out of the opening 927. The
suture 942 then extends along the outer surface 913 of the sleeve
912. The suture 942 then extends into the lumen 911 defined by the
sleeve 912 through the opening 925. The suture 942 then extends
within the lumen 911 and extends out of the opening 923. The suture
942 then extends along the outer surface 913 of the sleeve 912 and
extends into the lumen 911 through the opening 921. The suture 942
then passes through or is woven through the implant 902 and extends
from a bottom side of the implant 902.
In some embodiments, the suture 942 is woven through the implant
902 at multiple locations. In other embodiments, the suture 942
passes through the implant 902 one time. In some embodiments, the
suture 942 is woven through the implant 902.
As best illustrated in FIG. 3H, a bottom portion or surface 916 of
the sleeve 912 defines 2 openings or holes 924 and 926. The suture
942 extends from the lumen 911 of the sleeve 912 via opening 924.
The suture 942 then extends along an outer surface of the sleeve
912 and then extends into the lumen 911 via opening 926. The suture
942 then extends towards and is coupled to the dilator 922.
Accordingly, the dilator 922 is coupled to the sleeve 912 and the
implant 902 via the suture 942. As described above, the suture 942
forms a loop and is woven or threaded through the implant 902. In
the illustrated embodiment, the dilator 922 is also coupled to the
sleeve 912 via an additional coupling. For example, in some
embodiments, an end portion of the sleeve 912 is tacked or heat
welded to the dilator 922. In other embodiments, an adhesive is
used to couple the sleeve 912 to the dilator 922.
The medial device also includes an adjustment tab 950. The
adjustment tab 950 is coupled to a mid portion of the implant 902
and, as discussed in more detail below, may be used to adjust the
position of the implant 902 or the medical device 900 within the
body of the patient.
The adjustment tab 950 includes a first end portion 951, a second
end portion 953, and a mid-portion 952 disposed between the first
end portion 951 and the second end portion 953. In the illustrated
embodiment, the first end portion 951 is disposed adjacent to the
implant 902. The mid-portion 952 has a width that is smaller than
the width of the first end portion 951 and is smaller than then
width of the second end portion 953. In some embodiments, the
thinner mid-portion 952 of the adjustment tab 950 helps facilitate
the cutting of the suture 946 to remove the adjustment tab 950 from
the implant 902, as described in more detail below.
An elongate member or suture 946 couples the adjustment tab 950 to
the implant 902. In the illustrated embodiment, the suture 946 is
threaded or woven through the implant 902 (as best illustrated in
FIG. 3G) and forms a loop around the adjustment tab 950 (as best
illustrated in FIG. 3K). Specifically, in the illustrated
embodiment, the suture 946 extends through openings or lumens 971,
973, 975, and 977 defined by the first end portion 951 and the
second end portion 953. In the illustrated embodiment, the second
end portion 953 defines a groove 954 that is configured to receive
the suture 946. In some embodiments, the suture 946 is coupled to
the adjustment tab 950 within the groove 954 such as via an
adhesive or a frictional fit. In some embodiments, the suture 946
forms a knot and the knot is frictionally fit within the groove 954
defined by the second end portion 953 of the adjustment tab 950. In
some embodiments, the suture 946 may be cut (such as at a location
near the mid-portion 952 of the adjustment tab 950) and the
adjustment tab 950 can be pulled in a direction away from the
implant 902 to remove the adjustment tab 950 and the suture 946
from the implant 902. In such an embodiment, the suture 946 is
configured to pass through or be unwoven from the implant 902 in
response to the cutting of the suture 946 and the pulling of the
adjustment tab 950 in a direction away from the implant 902.
The medical device 900 may be inserted into the body using a
variety of different methods. Additionally, the medical device 900
may be placed or inserted into different locations within the body
to perform different functions. In some embodiment, the medical
device 900 is placed within a pelvic region of the patient and is
configured to provide support to a bladder, bladder neck, or
urethra of a patient.
In some embodiments, the medical device 900 can be inserted into a
body of a patient through a vaginal incision. For example, in some
embodiments, the medical device 900 may be placed into the body of
the patient using an outside-in procedure. In such embodiments, a
delivery device, such as a needle may be inserted into the body
such that the needle extends from a skin incision to a vaginal
incision, such as an anterior vaginal incision. In embodiments, a
curved needle, such as a curved or halo needle as sold by Boston
Scientific Corporation may be used. In some embodiments, the
delivery device passes though an obturator foramen of the patient
as it extends from the skin incision to the vaginal incision.
One end portion of the medical device 900, such as association loop
932, which is coupled to dilator 922, may be coupled to portion of
the delivery device that extends from the vaginal incision. The
delivery device, which is coupled to the medical device 900, may
then be removed or retracted through the skin incision. The medical
device 900 then extends from the vaginal incision to the skin
incision. The same procedure may be used to place the opposite end
portion of the medical device 900 using association loop 930, which
is coupled to dilator 920, on the contra lateral side of the
urethra. The implant may then be centered or moved such that the
implant 902 is disposed below the urethra.
The dilators 920 and 922 and sleeves 910 and 912 may then be
removed from the implant 902. For example, the dilator 922 and the
sleeve 912 may be removed by cutting the suture 942 and pulling the
dilator 922 from the skin incision in a direction away from the
body of the patient. In some embodiments, the suture 942 may be cut
at a location between openings 927 and 925 (where the suture 942
extends along an outer surface of the sleeve 912. The pulling of
the dilator 922 causes the suture to unravel or unweave from the
implant 902. Thus, the dilator 922, the sleeve 912 and the suture
942 may be removed leaving the implant 902 in place within the body
of the patient. A similar procedure may be used to remove the
dilator 920, sleeve 910, and suture 940. FIG. 3L is a schematic
illustration of the implant 902 disposed within a body of a
patient. The implant 902 is disposed below and is configured to
provide support to the urethra UA of the patient. Also, in the
illustrated embodiment, the implant 902 extends through the
obturator foramens of the patient.
In some embodiments, the adjustment tab 950 may be used to pull or
otherwise place the implant 902 into the correct position within
the body of the patient. In some embodiments, once the adjustment
tab 950 is no longer needed it may be removed from the body of the
patient. For example, the suture 946 may be cut and the adjustment
tab 950 may be pulled from the body and the implant 902. In some
embodiments, the adjustment tab 950 is removed from the body of the
patient through the vaginal incision. After the adjustment tab 950
is removed, the vaginal incision may be closed.
In other embodiments, the medical device 900 may be placed using
other techniques such as an outside-in technique. For example, in
some such embodiments, the medical device 900 may be placed with a
delivery device that is coupled to an end portion of the medical
device 900 and pushed into place within the body of the patient
through a vaginal incision.
FIGS. 4A and 4B illustrate C configuration of a sleeve such as the
sleeve 402. In the C configuration, the sleeve 402 encloses the
implant 404 in a manner that only a first side 406 (right side), a
second side 408 (left side), some portion of a first surface 410
(top surface), a second surface 412 (bottom surface) of the implant
404 are enclosed, whereas some portion of the first surface 410
(top surface) is exposed to bodily tissues and is not shielded
within the sleeve 402. The "some portion" can be along half of the
width of the sleeves 402, or about half of the width or lesser than
half of the width or slightly more than half of the width, and the
like as per the requirements.
FIGS. 4C and 4D illustrate a U configuration of the sleeve 402. The
U configuration encloses only the first side 406, the second side
408, and the second surface 412 (as shown in FIG. 4D), while the
first surface 410 (top surface) of the implant 404 is completely
exposed to the bodily tissues and not shielded within the sleeve
402. The "some portion" can be along half of the width of the
sleeves 402, or about half of the width or lesser than half of the
width or slightly more than half of the width, and the like as per
the requirements.
FIG. 6 illustrates an exemplary sleeve with folded ends. The sleeve
602 includes a proximal end portion 604 and a distal end portion
606. In some embodiments, the proximal end portion 604 and the
distal end portion 606 of the sleeve 602 can be tapered. The
tapered end facilitates withdrawal of the sleeve 602 without
disrupting the tissues. The distal end portion 606 of the sleeve
602 may be provided with a hole or opening 608 such that the hole
608 is configured to associate the sleeve 502 with the delivery
device. In some embodiments, the distal end portion 606 is
associated with one of a dilator, a tube, an association loop and a
connector. In an exemplary embodiment, the total length of the
sleeve can be 12.5 cm such that the proximal end portion 604 has a
length of 2.5 cm whereas the distal end portion 606 has a length of
1.0 cm, as shown in FIG. 6. It must be appreciated that the sleeve
502 can be used in the medical assembly 100 or 200 as described
above.
FIG. 7 illustrates placement of an implant in a patient's body, in
accordance with an embodiment of the present invention. The medical
assembly 200 is hereafter used for describing placement of the
implant such as the implant 202. The implant 202 is inserted inside
the body of the patient through a vaginal incision 702 and placed
under urethra 704 in a manner that the mid portion 220 of the
implant 202 conforms the contour of the urethra 704.
FIG. 8 illustrate a flow chart representing a method 800 for the
delivery of the medical assembly 200 in a patient's body, in
accordance with some embodiments of the present invention. The
method 800 includes creating a vaginal incision for inserting the
medical assembly 200 inside the patient's body. The medical
assembly 200 having the bodily implant 202 can be used to treat
incontinence. The medical assembly 200 is inserted into the
patient's body at step 802. The bodily implant 202 includes an end
portion such that the end portion is enclosed in a sleeve. The
sleeve is further coupled to the bodily implant 202 by an elongate
member through frictional resistance. In some embodiments, the
bodily implant 202 includes a first portion 216 and a second
portion 218 such that the first portion and the second portion are
enclosed respectively in the first sleeve 204 and the second sleeve
206. The first sleeve 204 and the second sleeve 206 are coupled to
the first portion 216 and the second portion 218 of the implant 202
by an elongate member such as the elongate member 280. After
inserting the medical assembly 200 inside the patient's body, the
implant 202 is placed underneath the urethra of the patient at step
804 such that the mid portion 220 of the implant 202 that is
exposed to a bodily tissue contacts the bodily tissue. In
accordance with various embodiments, since the first portion 216
and the second portion 218 are covered by the sleeves 204 and 206,
therefore, only the mid portion 220 contacts the bodily tissue
directly.
In some embodiments, the position of the bodily implant 202 may be
adjusted. The bodily implant 202 is adjusted in a manner that the
bodily implant 202 contours an outer surface of the urethra that is
in contact with the bodily implant 202. The physician may further
adjust tension of the implant 202 to readjust the bodily implant
202 to provide it an appropriate tension for effective placement
and treatment. The tensioning of the implant 202 may require
stretching of the implant 202. The stretch area that is stretched
is substantially the mid portion 220 such that when the physician
stretches the implant 202, only the mid portion 220 is stretched
while the end portions are restricted from stretching because the
end portions are covered within the sleeves 204 and 206 while the
mid portion 220 is exposed to the bodily tissues. In some
embodiments, the end portions may also stretch slightly. As the
stretch portion or the mid portion 220 stretches while tensioning
of the implant 202, the elongate member 280 shielded within the
implant 202 compensates for an additional length required. This may
prevent unraveling of the elongate member 280 from the implant 202.
In some embodiments, tensioning forces may be transferred from the
implant 202 to the sleeves 204 and 206 by the elongate member 280
preventing the stretching of the implant 202 within the sleeves 204
and 206. The interaction of the mid portion 220 of the implant 202
with the bodily tissues underneath the urethra provides the
physician with a visual and a tactile feedback through the mid-line
or skin incision.
After tensioning the implant 202, the method 800 further includes
pulling the elongate member 280 outside the patient's body such
that a pulling of the elongate member 280 releases the first and
second sleeves 204 and 206 from the bodily implant 202 at step 806.
It must be recognized that the elongate member 280 or portions of
the elongate member 280 can be removed in a single or different
directions through various incisions.
In some embodiments, the loop 260 formed by the elongate member 280
near the mid portion 220 of the implant 202 can be pulled by the
physician such that pulling the loop 282 decouples the sleeves 204
and 206 from the implant 202 thereby releasing the first sleeve 204
and the second sleeve 206.
In some embodiments, the loop 282 formed by the elongate member 280
near the mid portion 220 of the implant 202 is cut. Cutting the
loop 282 in this manner provides two portions of the elongate
member 280 with two free ends such that pulling the two portions of
the elongate member 210 separately at the free ends releases the
first sleeve 204 and the second sleeve 206. In some embodiments,
the first and the second portion of the elongate member 280 can be
pulled through the vaginal opening. However, in some embodiments,
the first and the second portion of the elongate member 280 can be
pulled through groin incisions or through an obturator foreman. In
some other embodiments, the first and the second portion of the
elongate member 280 can be pulled through the skin incisions.
In accordance with the embodiments described above, the sleeves 204
and 206 are coupled to the implant 202 with the single elongate
member 280. In some other embodiments, however, the implant can be
coupled to the sleeves 204 and 206 through two elongate members
that may be referred to as the first elongate member 210 and the
second elongate member 212. In some embodiments, the first elongate
member 210 and the second elongate member 212 can further be
coupled to the tab 208. The tab 208 can also be coupled to the
implant 202 through the third elongate member 214. In some
embodiments, the third elongate member 214 can be cut to
disassociate the implant 202 from the tab 208. After cutting the
third elongate member 214, the tab 208 is pulled through the
vaginal opening such that pulling of the tab 208 releases the
sleeves 204 and 206 from the bodily implant 202. While the third
elongate member 214 is cut, the tab 208 is still coupled to the
implant through the first and the second elongate member 210 and
212. Therefore, the pulling of the tab 208 disassociates the first
elongate member 210 and the second elongate member 212 thereby
removing the first sleeve 204 and the second sleeve 206 from the
implant 202. Since the frictional resistance that holds the implant
202 and the sleeves 204 and 206 is easily overcome by the pulling
of the tab 208, the sleeves 204 and 206 get decoupled from the
implant 202. Also, a small contact surface area between the sleeves
204 and 206 and the implant 202 because the sleeves 204 and 206
cover substantially half of the implant length prevents an
alteration of the implant tension caused by pulling of the tab
208.
In some other embodiments, the first elongate member 210 and the
second elongate member 212 can be cut just above the tab 208 such
that the end portions of the first elongate member 210 and the
second elongate member 212 gets free. The physician or the operator
can then pull the free ends of the first elongate member 210 and
the second elongate member 212 in a direction of the vaginal
incision or the skin incisions thereby releasing the first sleeve
204 and the second sleeve 206. In an embodiment, the first sleeve
204 and the second sleeve 206 can be removed or pulled out of the
body along with the first elongate member 210 and the second
elongate member 212 respectively, through the skin incisions.
In some embodiments, such as those illustrated in FIGS. 3A-3C, the
excess slack, for example, at the first portion 336 of the first
elongate member 306 can be cut to release the implant 302 from the
first sleeve 304 thereby resulting in two free ends of the first
elongate member 306. The first dilator 348, external to the body,
is pulled in the direction along the vaginal opening or incision.
In another embodiment, the first dilator 348 is pulled along and in
a direction different from a direction of the vaginal opening or
incision. In such examples, the direction of pulling can be along
any other bodily opening or a passageway created through incisions
along a body portion such as skin incisions, groin incisions,
midline incisions, incisions in thigh, buttock or any other bodily
location. The dilator 348 is pulled out through the passageway thus
created such as through the skin incisions. In an embodiment, the
dilator 348 can be pulled out while one end of the first elongate
member 306 is still attached to the medical assembly 300. The cut
free end of the first elongate member 306 unthreads from the first
sleeve 304 and the implant 302. The cut free end of the first
elongate member 306 unthreads across holes of the top layer 314 and
holes of the bottom layer 316 of the first sleeve 304 thereby
decoupling the first sleeve 304 from the implant 302, and removing
the first elongate member 306 or the first dilator 348 from the
body. The first elongate member 306 travels from the top layer 314
to the bottom layer 316 as the first dilator 348 is pulled. The
first sleeve 306 along with the first elongate member 306 is
removed as a single part through the passageway that can be the
vaginal opening or the skin incision. In an embodiment, the second
elongate member 330 can be decoupled from the implant 302 and the
second sleeve 326 in a similar manner as described above.
The first sleeve 204 is pulled along with and in a direction of
pulling the first elongate member 210 such as through skin
incision. In an embodiment, the first elongate member 210 and the
first sleeve 204 can be removed without cutting the first sleeve
204. In some embodiments, the second sleeve 206 is pulled along
with and in a direction of pulling the second elongate member 212
such as through skin incision. In an embodiment, the second
elongate member 212 and the second sleeve 206 can be removed
without cutting the second sleeve 206.
Referring again to the medical assembly 200, in some embodiments,
the first elongate member 210 and the second elongate member 212
are coupled together separately from the tab 208. In such
embodiments, the sleeves 204 and 206 can be decoupled by cutting
the first and second elongate members 210 and 212 while the tab 208
still coupled to the implant 202 through the third elongate member
214.
Referring again to the embodiment using a single elongate member,
upon separation of the first and second sleeves 204 and 206 from
the implant 202, the first sleeve 204 and the second sleeve 206 can
be pulled along with the elongate member from the body through skin
incisions. In an example, the first sleeve 204 and the second
sleeve 206 are pulled out from the patient's body along with the
elongate member through two incisions provided in an abdomen or in
an obturator area of the patient or through various other skin
incisions.
In accordance with some embodiments, the method further includes
trimming a portion of the bodily implant 202. The trimmed portion
can be tucked to the bodily tissues under skin. In some
embodiments, trimming of the implant 202 may not be required as the
complete length of the implant 202 acts as a working length. In
accordance with various embodiments, the vaginal incision, groin
incisions, abdomen incision, or any other skin incision are
closed.
It must be appreciated that the above description provides an
exemplary treatment procedure, while in some other embodiments; the
medical assembly and the method can be used for other treatment
purposes such as for various pelvic floor disorders. In accordance
with the described embodiments, a transbturator sling or a surgical
approach may be utilized.
In some embodiments, a medical assembly includes an implant having
a first portion, a second portion and a mid portion between the
first portion and the second portion; a first sleeve configured to
enclose the first portion of the implant and a second sleeve
configured to enclose the second portion of the implant; a tab
coupled to the implant; a first elongate member configured to
removably couple the implant with the first sleeve, wherein the
first elongate member extends from the first portion to the mid
portion of the implant and past the mid portion and exits the
implant through the mid portion; a second elongate member
configured to removably couple the implant with the second sleeve,
wherein the second elongate member extends from the second portion
to the mid portion of the implant and past the mid portion and
exits the implant through the mid portion, wherein the first
elongate member and the second elongate member are coupled to the
tab and to each other at the tab; and a third elongate member
configured to pass through the mid portion of the implant and form
a loop configured to couple the mid portion of the implant with the
tab.
In some embodiments, the first sleeve and the second sleeve
together encloses a maximum of half of a total length of the
implant. In some embodiments, the first sleeve and the second
sleeve are thin walled flat tubes configured to enclose at least
some portion of the implant at ends.
In some embodiments, the device includes a first dilator configured
to be coupled to the first sleeve, and a second dilator configured
to be coupled to the second sleeve.
In some embodiments, the first elongate member, the second elongate
member and the third elongate member include one of a thread, and a
medical suture.
In some embodiments, each of the first elongate member and the
second elongate member has a single suture running along a portion
of length of the implant. In some embodiments, each of the first
elongate member and the second elongate member has multiple sutures
running along a portion of length of the implant adjacent one
another.
In some embodiments, a medical assembly includes an implant having
a first portion, a second portion and a mid portion between the
first portion and the second portion; a first sleeve configured to
enclose the first portion of the implant and a second sleeve
configured to enclose the second portion of the implant; and an
elongate member configured to removably couple the implant with the
first sleeve and the second sleeve, wherein the elongate member is
configured to extend from the first portion to the mid portion of
the implant and past the mid portion such that the elongate member
exits the implant through the mid portion and forms a loop near the
mid portion, the elongate member further configured to enter the
implant through the mid portion and extend from the mid portion to
the second portion of the implant.
In some embodiments, the elongate member is configured to couple
the implant with the first sleeve and the second sleeve through
frictional resistance. In some embodiments, the first sleeve and
the second sleeve together encloses a maximum of half of a total
length of the implant.
In some embodiments, the device includes a first dilator configured
to be coupled to the first sleeve, and a second dilator configured
to be coupled to the second sleeve.
In some embodiments, the first sleeve and the second sleeve are
thin walled flat tubes configured to enclose at least a portion of
the implant.
In some embodiments, a medical assembly includes an implant having
a first portion, a second portion and a mid portion between the
first portion and the second portion; a sleeve with a top layer, a
bottom layer, and a lumen defined between the top layer and the
bottom layer, a first hole provided on the top layer, a second hole
provided on the bottom layer, wherein the first hole and the second
hole are respectively defined along a thickness of the top layer
and the bottom layer; and an elongate member configured to pass
through the first hole, along the lumen and the second hole and
couple the implant with the sleeve.
In some embodiments, the sleeve is a first sleeve, the medical
assembly further including a second sleeve with a top layer, a
bottom layer, and a lumen defined between the top layer and the
bottom layer, a first hole provided on the top layer, a second hole
provided on the bottom layer, wherein the first hole and the second
hole are respectively defined along a thickness of the top layer
and the bottom layer of the second sleeve.
In some embodiments, the elongate member is a first elongate
member, the medical assembly further including a second elongate
member configured to pass through the first hole, along the lumen
and the second hole and couple the implant with the second
sleeve.
In some embodiments, the device includes a tab configured to be
coupled with the implant through a third elongate member. In some
embodiments, the implant is a mesh based device, the elongate
member configured to pass through a mesh cell of the implant. In
some embodiments, the implant is a non-mesh based device, the
non-mesh based device further including a hole configured to
facilitate passing of the elongate member along the implant through
the hole. In some embodiments, the elongate member includes a
portion laid at a surface external to the top layer or the bottom
layer that is configured to provide a slack in the elongate member
and configured to facilitate decoupling of the sleeve from the
implant.
In some embodiments, a medical assembly includes an implant having
a first portion, a second portion and a mid portion between the
first portion and the second portion; a first sleeve configured to
enclose the first portion of the implant; a first dilator
configured to couple with the first sleeve; and a first elongate
member configured to couple the first sleeve and the first portion
of the implant such that a first portion of the first elongate
member extends along the sleeve and lay external to the sleeve
while a second portion of the first elongate member extends through
a lumen of the first sleeve and across the implant, the first
elongate member extending between the first dilator and the first
sleeve to form a loop structure of threading.
In some embodiments, the first sleeve includes a top layer, a
bottom layer, and a lumen defined between the top layer and the
bottom layer, a first hole provided on the top layer, a second hole
provided on the bottom layer, wherein the first hole and the second
hole are respectively defined along a thickness of the top layer
and the bottom layer. In some embodiments, the device includes a
second sleeve with a top layer, a bottom layer, and a lumen defined
between the top layer and the bottom layer, a first hole provided
on the top layer, a second hole provided on the bottom layer,
wherein the first hole and the second hole are respectively defined
along a thickness of the top layer and the bottom layer of the
second sleeve. In some embodiments, the first elongate member
extends from the first dilator, across a portion of the first
sleeve, along a lumen of the first sleeve, across a portion of the
implant and extends back to the first dilator forming the loop. In
some embodiments, the first elongate member and the first sleeve
are together configured to be pulled out of the body through skin
incisions upon implantation of the implant under urethra without
cutting the first sleeve. In some embodiments, the assembly
includes a second dilator and a second elongate member, wherein the
second elongate member extends from the second dilator, across a
portion of the second sleeve, along a lumen of the second sleeve,
across a portion of the implant and extends back to the second
dilator forming a loop. In some embodiments, the first dilator and
the second dilator are each configured to be coupled to a delivery
device to facilitate delivery of the medical assembly including the
implant within the patient's body. In some embodiments, the second
elongate member and the second sleeve are together configured to be
pulled out of the body through skin incisions upon implantation of
the implant under urethra without cutting the second sleeve. In
some embodiments, the first elongate member extends along an entire
lumen defined by the first dilator such that a portion of the first
elongate member stay outside the lumen, the portion staying outside
being configured to be pulled by an operator to remove the elongate
member from the body.
In some embodiments, a method for placing an implant for the
treatment of urinary incontinence in a patient's body, the method
includes inserting a medical assembly having a bodily implant into
a patient's body such that a first end portion and a second end
portion of the bodily implant are enclosed in a first sleeve and a
second sleeve respectively, the first sleeve being coupled to the
implant by an elongate member through frictional resistance;
placing the implant underneath a urethra of a patient such that a
mid portion of the implant is exposed to a bodily tissue; and
pulling the elongate member outside the patient's body such that a
pulling of the elongate member releases the first sleeve from the
bodily implant.
In some embodiments, the method includes creating a vaginal
incision for inserting the medical assembly inside the patient's
body. In some embodiments, the method includes adjusting the
position of the bodily implant such that the bodily implant
contours an outer surface of the bodily tissue that is in contact
with the bodily implant. In some embodiments, the method includes
adjusting tension and position of the implant based on a tactile
and a visual feedback. In some embodiments, the method includes
trimming a portion of the bodily implant.
In some embodiments, the elongate member is configured to couple
the second sleeve with the second end portion, and the pulling of
the elongate member is configured to release the second sleeve from
the bodily implant and; remove the second sleeve along with the
elongate member from the body through skin incisions.
In some embodiments, the elongate member is a first elongate
member, the medical assembly further includes a second elongate
member coupling the second sleeve with the second end portion of
the implant, the method includes pulling the second elongate member
along with the second sleeve through skin incisions.
In some embodiments, the method includes closing the vaginal
incision and the skin incisions.
While the invention has been disclosed in connection with the
preferred embodiments shown and described in detail, various
modifications and improvements thereon will become readily apparent
to those skilled in the art. Accordingly, the spirit and scope of
the present invention is not to be limited by the foregoing
examples, but is to be understood in the broadest sense allowable
by law.
* * * * *